Page 8 - Safety Risk Management for Medical Devices

CONTENTS

List of Figures xiii
List of Tables xv
Biography xvii
Preface xix

1. Introduction 1

2. Why Do Risk Management? 3
2.1 Legal and Regulatory Requirements 4
2.2 Business Reasons 5
2.3 Moral and Ethical Reasons 7

3. The Basics 9
3.1 Vocabulary of Risk Management 9
3.2 Hazard Theory 13
3.3 System Types 13

4. Understanding Risk 15
4.1 Risk Definitions 16
4.2 Types of Risk 17
4.3 Contributors to Risk 17
4.4 Risk Perception 18
4.5 Risk Computation 19

5. Risk Management Standards 23
5.1 ISO 14971 History and Origins 23
5.2 Harmonized Standards 24

6. Requirements of the Risk Management Process 25
6.1 Risk Management Process 25

7. Quality Management System 29

8. Usability Engineering and Risk Analysis 31
8.1 Key Terms 32
8.2 Distinctions 34
8.3 User-Device Interaction Model 34

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